Страна: Канада
Език: английски
Източник: Health Canada
BENZYDAMINE HYDROCHLORIDE
NOVOPHARM LIMITED
A01AD02
BENZYDAMINE
1.5MG
SOLUTION
BENZYDAMINE HYDROCHLORIDE 1.5MG
BUCCAL
100ML/250ML
Prescription
NONSTEROIDAL ANTI-INFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0113801001; AHFS:
CANCELLED POST MARKET
2018-05-17
1 PRODUCT MONOGRAPH Pr NOVO-BENZYDAMINE (Benzydamine Hydrochloride Oral Rinse 0.15% w/v) Local Analgesic Novopharm Limited 30 Novopharm Court Toronto, Ontario M1B 2K9 Submission Control No: 121722 Date of Preparation: May 14, 2008 2 PRODUCT MONOGRAPH PR NOVO-BENZYDAMINE (Benzydamine Hydrochloride Oral Rinse 0.15% w/v) THERAPEUTIC CLASSIFICATION Local Analgesic ACTIONS AND CLINICAL PHARMACOLOGY Animal studies using parenteral route have shown that benzydamine hydrochloride possesses properties of an analgesic/anti-inflammatory agent. This effect is not mediated through the pituitary-adrenal axis. Studies using the topical route have demonstrated local anesthetic properties of benzydamine hydrochloride. In controlled studies in humans with oro-pharyngeal mucosity due to radiation therapy, benzydamine hydrochloride oral rinse use has provided relief through reduction of pain and edema. Similar studies in patients with acute sore throat demonstrated relief from pain. Benzydamine hydrochloride has been detected in blood and urine after gargling four times for 20 2seconds, in rapid succession, each time with a volume equivalent to 25.5 mg benzydamine per 70 kg body weight (approximately 17 mL per gargle). The average maximum plasma level of 59 ng/mL (range 17 to 173) was obtained 2 hours after gargling. For comparison, one dose of 17 mL, when swallowed, yielded an average maximum plasma level of 180 ng/ mL (range 102 to 324), also at 2 hours after ingestion. Benzydamine was still detectable 24 hours later in 7 out of 10 subjects after the gargling (average plasma level of 7 ng/mL) and in 9 out of 10 subjects after the ingestion (average 32 ng/mL). The urinary excretion was completed within 3-4 days after the single dose in both groups; about 46% of the dose was recovered in garglers, about 26% in ingestors. Repeated administration for 7 days did not result in a significant accumulation of benzydamine hydrochloride in plasma. INDICATIONS AND CLINICAL USE NOVO-BENZYDAMINE (benzydamine hydrochloride) Oral Rinse is indicat Прочетете целия документ